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COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

by Zhejiang Orient Gene Biotech Co., Ltd 4 variants

Ref GCFCRA-T525a-DRH5Model GCFCRA-T525a-DRH1，GCFCRA-T525a-DRH5，GCFCRA-T525a-DRH7，GCFCRA-T525a-DRH20

Active European Union

CE IVDR

Valid until

1 Apr 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6188440CE01 Date1 Sep 2026IssuedStatusActive expires 1 Apr 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6188440CE01 Active Supplemented

    Quality management system EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Sep 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group
  • 6188440TD01 Active

    Technical documentation EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Apr 2025
    Expires
    1 Apr 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
GCFCRA-T525a-DRH1，GCFCRA-T525a-DRH5，GCFCRA-T525a-DRH7，GCFCRA-T525a-DRH20, GCFCRA-T525a-DRH5
Primary DI / UDI-DI
06950996002813
Basic UDI-DI
69509960GCFCRA-T525aDRH6M
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

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Properties

  • Reagent
  • Self Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No